Traditional vaginal treatments include ointments, pessaries, creams or gel-type formulations, which can be inconvenient and messy for the patient as well as tricky to administer and likely to leak.
Furthermore, residence time of a composition comprising an active ingredient at the site of application is known to be critically affected by the consistency of the pharmaceutical composition, therefore a non optimized vehicle can negatively affect the therapeutic efficacy.
The problem is particularly critical in the case of intravaginal administration, since a poorly viscous composition is immediately diluted and expelled. On the other hand, a composition with high consistency, such as a cream, prevents the diffusion of the active ingredient, thus limiting its activity to the site of deposition only. Furthermore, a reduced drug diffusion may cause irritation and local side effects. The use of foamable compositions to deliver the active ingredient to the vagina as a foam has been found to be particularly effective.
Insertable devices adapted for delivery of a material to the vagina are known. For example, vaginal douches are used to apply a stream of douching fluid to the vaginal canal of the user. Examples of vaginal douches are disclosed in U.S. Pat. Nos. 1,666,684; 6,190,365; and 5,013,297, and in PCT application WO 03/070301. Vaginal douches are intended for application of a liquid to the vagina, and the use of such douches for delivery of a foam is not discussed. Furthermore, the dimensions of the tube are not configured for delivery of a foam composition. Similarly, a swab applicator for use as a vaginal cleaning instrument is disclosed in U.S. Pat. No. 4,329,990, having fluid passages to enhance its wetting by liquid dispensed through a nozzle. These passages are intended for dispensing liquids only, and not foams, and the applicator dimensions are not selected for delivery of a foam.
A vaginal applicator for use with pressurized containers is disclosed in U.S. Pat. No. 3,154,075, which may be used for administering a foam. The applicator is provided with horizontal grooves for venting pressure built up within the vagina during use. These grooves are not intended to be of sufficient width to provide an outlet for the foam. Instead, material is dispended through the open tip end of the applicator, which prevents even application of a foam composition to the vaginal wall. The dimensions of the applicator are not disclosed.
U.S. Pat. No. 2,767,712 teaches a vaginal applicator for application of jellies or semi-viscous materials. The contents are forced out under pressure through radially distributed outlets. The effect of dimensions of the applicator and of the arrangement of the apertures provided in the dispenser is not addressed.
U.S. Pat. No. 6,364,854 teaches a vaginal applicator for semi-solid medications, which is pre-filled with a medication which is discharged via one or more openings at the dispensing end. The use of such a device for dispensing a foam is not taught, nor is the provision of dispensing openings at positions other than at the distal end. The effect of dimensions of the applicator on delivery of the medication is not taught.
U.S. Pat. No. 1,159,250 teaches a vaginal irrigator for connecting to a hose, having spray openings adjacent to its extremity. The use of such a device for dispensing a material other than a liquid is not disclosed, nor is the provision of dispensing openings at positions other than at the distal end.
An additional vaginal irrigation apparatus is disclosed in U.S. Pat. No. 4,309,995, which teaches a probe portion constructed entirely of polyurethane, which has an open cellular construction to disperse medicament readily. The use of such an apparatus for dispensing a foam composition is not taught.
U.S. Pat. No. 3,540,448 describes a rechargeable applicator for dispensing substances in a foam condition into a body cavity.
The known dispensing devices are not configured to provide a high degree of control over the ejection speed and efficiency of dispensing of a foam composition. The use of such a device having optimal dimensions and aperture arrangements is not disclosed in the background art.
There is thus a widely recognized need for, and it would be highly advantageous to have, a vaginal applicator device devoid of at least some of the above limitations.
It would also be highly advantageous to have, a body cavity applicator device for use in other body cavities such as the rectum including deep body cavities such as the colon, small intestine, stomach and bladder devoid of at least some of the above limitations.